[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Rules and Regulations]
[Pages 61170-61171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27856]



[[Page 61170]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. FDA-2017-N-6855]


Medical Devices; Radiology Devices; Classification of the Rectal 
Balloon for Prostate Immobilization

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the rectal balloon for prostate immobilization into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the rectal balloon for prostate immobilization's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective December 27, 2017. The classification 
was applicable on January 28, 2014.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the rectal balloon for prostate 
immobilization as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by reducing regulatory burdens by 
placing the device into a lower device class than the automatic class 
III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device 
that does not require premarket approval. We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 established the first procedure for De Novo classification 
(Pub. L. 105-115). Section 607 of the Food and Drug Administration 
Safety and Innovation Act modified the De Novo application process by 
adding a second procedure (Pub. L. 112-144). A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s. As a result, other device sponsors do 
not have to submit a De Novo request or PMA in order to market a 
substantially equivalent device (see 21 U.S.C. 360c(i), defining 
``substantial equivalence''). Instead, sponsors can use the less-
burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On July 15, 2013, RadiaDyne, LLC submitted a request for De Novo 
classification of the prostate immobilizer rectal balloon. FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on January 28, 2014, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 892.5720. We have named 
the generic type of device rectal balloon for prostate immobilization, 
and it is identified as a single use, inflatable, non-powered 
positioning device placed in the rectum to immobilize the prostate in 
patients undergoing radiation therapy. The device is intended to be 
used during all the phases of radiation therapy, including treatment 
planning, image verification, and radiotherapy delivery.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

[[Page 61171]]



Table 1--Rectal Balloon for Prostate Immobilization Risks and Mitigation
                                Measures
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                                                    Mitigation measures/
                 Identified risks                      21 CFR section
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Anorectal Toxicity...............................  Special controls
                                                    (1)(i) (21 CFR
                                                    892.5720(b)(1)(i)),
                                                    (1)(ii) (21 CFR
                                                    892.5720(b)(1)(ii)),
                                                    (1)(iii) (21 CFR
                                                    892.5720(b)(1)(iii))
                                                    , (1)(iv) (21 CFR
                                                    892.5720(b)(1)(iv)),
                                                    (2)(i)(D) (21 CFR
                                                    892.5720(b)(2)(i)(D)
                                                    ), (2)(ii) (21 CFR
                                                    892.5720(b)(2)(ii)),
                                                    (2)(iii) (21 CFR
                                                    892.5720(b)(2)(iii))
                                                    , and (2)(iv) (21
                                                    CFR
                                                    892.5720(b)(2)(iv)).
Tissue Damage....................................  Special controls
                                                    (1)(iv) (21 CFR
                                                    892.5720(b)(1)(iv)),
                                                    (1)(v) (21 CFR
                                                    892.5720(b)(1)(v)),
                                                    (2)(i)(A) (21 CFR
                                                    892.5720(b)(2)(i)(A)
                                                    ), (2)(i)(D) (21 CFR
                                                    892.5720(b)(2)(i)(D)
                                                    ), (2)(ii) (21 CFR
                                                    892.5720(b)(2)(ii)),
                                                    (2)(iii) (21 CFR
                                                    892.5720(b)(2)(iii))
                                                    , and (2)(iv) (21
                                                    CFR
                                                    892.5720(b)(2)(iv)).
Perforation of the Rectum........................  Special controls
                                                    (1)(v)(A) (21 CFR
                                                    892.5720(b)(1)(v)(A)
                                                    ), (1)(v)(B) (21 CFR
                                                    892.5720(b)(1)(v)(B)
                                                    ), (2)(i)(A) (21 CFR
                                                    892.5720(b)(2)(i)(A)
                                                    ), (2)(i)(D) (21 CFR
                                                    892.5720(b)(2)(i)(D)
                                                    ), (2)(ii) (21 CFR
                                                    892.5720(b)(2)(ii)),
                                                    (2)(iii) (21 CFR
                                                    892.5720(b)(2)(iii))
                                                    , and (2)(iv) (21
                                                    CFR
                                                    892.5720(b)(2)(iv)).
Irradiation of Healthy Tissue....................  Special controls
                                                    (1)(v)(A) (21 CFR
                                                    892.5720(b)(1)(v)(A)
                                                    ), (1)(v)(B) (21 CFR
                                                    892.5720(b)(1)(v)(B)
                                                    ), (2)(i)(B) (21 CFR
                                                    892.5720(b)(2)(i)(B)
                                                    ), (2)(ii) (21 CFR
                                                    892.5720(b)(2)(ii)),
                                                    (2)(iii) (21 CFR
                                                    892.5720(b)(2)(iii))
                                                    , and (2)(iv) (21
                                                    CFR
                                                    892.5720(b)(2)(iv)).
Patient Intolerance..............................  Special controls
                                                    (1)(v)(A) (21 CFR
                                                    892.5720(b)(1)(v)(A)
                                                    ), (2)(i)(A) (21 CFR
                                                    892.5720(b)(2)(i)(A)
                                                    ), (2)(i)(C) (21 CFR
                                                    892.5720(b)(2)(i)(C)
                                                    ), (2)(ii) (21 CFR
                                                    892.5720(b)(2)(ii)),
                                                    (2)(iii) (21 CFR
                                                    892.5720(b)(2)(iii))
                                                    , and (2)(iv) (21
                                                    CFR
                                                    892.5720(b)(2)(iv)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the guidance document ``De Novo Classification Process (Evaluation of 
Automatic Class III Designation)'' have been approved under OMB control 
number 0910-0844; the collections of information in 21 CFR part 814, 
subparts A through E, regarding premarket approval, have been approved 
under OMB control number 0910-0231; the collections of information in 
part 807, subpart E, regarding premarket notification submissions, have 
been approved under OMB control number 0910-0120; and the collections 
of information in 21 CFR part 801, regarding labeling, have been 
approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 892

    Medical devices, Radiation protection, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
892 is amended as follows:

PART 892--RADIOLOGY DEVICES

0
1. The authority citation for part 892 is revised to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  892.5720 to subpart F to read as follows:


Sec.  892.5720  Rectal balloon for prostate immobilization.

    (a) Identification. A rectal balloon for prostate immobilization is 
a single use, inflatable, non-powered positioning device placed in the 
rectum to immobilize the prostate in patients undergoing radiation 
therapy. The device is intended to be used during all the phases of 
radiation therapy, including treatment planning, image verification, 
and radiotherapy delivery.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The premarket notification submission must include methodology 
and results of the following non-clinical and clinical performance 
testing:
    (i) Biocompatibility testing of the final finished device;
    (ii) If provided sterile, sterilization validation;
    (iii) If not provided sterile, bioburden testing of the final 
finished device;
    (iv) Shelf life and expiration date validation; and
    (v) Performance testing including but not limited to:
    (A) Venting mechanism (if device has a vent mechanism);
    (B) Safety mechanism(s) to prevent advancement beyond its intended 
safe placement; and
    (C) Structural integrity testing (e.g., tensile strength, balloon 
leakage and burst strength).
    (2) Labeling that includes:
    (i) Appropriate warnings and contraindications, including, but not 
limited to the following statements:
    (A) ``Do not transport the patient with the rectal balloon 
inserted. The balloon should be removed prior to transport.'';
    (B) ``Failure to perform the standard imaging position verification 
protocol may cause the device to not perform as intended.'';
    (C) ``Reduce the rectal balloon fill volume if the patient 
experiences discomfort due to the rectal balloon inflation.''; and
    (D) ``Do not apply excessive pressure/force on the shaft or tubing 
of the rectal balloon.''
    (ii) Adequate instructions for use on the proper insertion 
procedure, positioning, and inflation of the rectal balloon;
    (iii) Whether the device is sterile or non-sterile; and
    (iv) An expiration date.

    Dated: December 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27856 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P